IP Library › Granted Patent US 12,514,632
Granted Patent B2
US 12,514,632 · App. 17/119,783 · Granted Jan 6, 2026

Tissue mapping and treatment

Inventor: Brian Schuler (York, PA)
Assignee: Biozonal ID, LLC
A61B18/1492A61B2018/00077A61B2018/00267A61B2018/00577A61B2018/00791A61B2018/144
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,514,632
App. No.
17/119,783
Granted
Jan 6, 2026
Kind
B2
Abstract

Methods, systems, and devices are described for mapping and treating tissue during a medical procedure. In some cases, a device includes a mesh of wires with sensors coupled thereto. The mapping device can be coupled to an expandable treatment element. Alternatively, the treatment device can be a separate device, and advanced through an access lumen in the mapping device. The expandable treatment element can include multiple segments. The sensors can be used to map a tissue area and monitor the tissue during a medical procedure.

Claims (31)

1 . A system for determining a control parameter of a treatment device configured to treat atrial fibrillation, the system comprising one or more hardware processors configured to:

determine a threshold energy (“E1”) needed to stimulate a non-targeted tissue proximate a target tissue site;

receive one or more electrical signals responsive to stimulation of the non-targeted tissue;

determine a change in the one or more received electrical signals corresponding to a physical change in the target tissue site, said physical change responsive to treatment of tissue at the target tissue site; and

determine a control parameter based on the threshold energy and a first time (“T1”) corresponding to the determination of the change in the one or more received electrical signals,

wherein the control parameter comprises a treatment time (“Tt”) corresponding to an amount of time for operation of the treatment device, and

wherein the treatment time is a function of a ratio of the determined threshold energy over a predetermined constant threshold (“E2”) corresponding to a safe distance from the non-targeted tissue.

2 . The system of claim 1 , wherein the treatment time is a function of a predetermined treatment time (“Ts”) at the safe distance from the non-targeted tissue.

3 . The system of claim 2 , wherein Tt=T1+ [(E1/E2)×Ts].

4 . The system of claim 3 , wherein the predetermined threshold energy is about 20 mA.

5 . The system of claim 3 , wherein the predetermined treatment time is about 180 seconds.

6 . The system of claim 1 , wherein the threshold energy corresponds to a rheobase curve for the non-targeted tissue.

7 . The system of claim 1 , wherein the one or more hardware processors are further configured to automatically predict treatment success based on the received one or more electrical signals.

8 . The system of claim 7 , the treatment success is determined based on the first time corresponding to the determination of the change in the one or more received electrical signals.

9 . The system of claim 7 , wherein the treatment success is further determined based on a spatial pattern of the change in the one or more received electrical signals.

10 . A method of adjusting therapy delivered by a treatment device configured to treat atrial fibrillation, the method comprising:

determining a threshold energy (“E1”) needed to stimulate a non-targeted tissue proximate a target tissue site;

receiving one or more electrical signals responsive to stimulation of the non-targeted tissue;

determining a change in the one or more received electrical signals corresponding to a physical change in the target tissue site, said physical change responsive to treatment of tissue at the target tissue site;

determining a control parameter based on the threshold energy and a first time (“T1”) corresponding to the determination of the change in the one or more received electrical signals; and

adjusting the treatment device to modify a parameter of therapy in response to the control parameter,

wherein the control parameter comprises a treatment time (“Tt”) corresponding to an amount of time for operation of the treatment device, and

wherein the treatment time is a function of a ratio of the determined threshold energy over a predetermined constant threshold (“E2”) corresponding to a safe distance from the non-targeted tissue.

11 . The method of claim 10 , wherein the treatment time is a function of a predetermined treatment time (“Ts”) at the safe distance from the non-targeted tissue.

12 . The method of claim 11 , wherein Tt=T1+ [(E1/E2)×Ts].

13 . The method of claim 12 , wherein the predetermined threshold energy is about 20 mA.

14 . The method of claim 12 , wherein the predetermined treatment time is about 180 seconds.

15 . The method of claim 10 , wherein the threshold energy corresponds to a rheobase curve for the non-targeted tissue.

16 . The method of claim 10 , further comprising automatically predicting treatment success based on the received one or more electrical signals.

17 . The method of claim 16 , the treatment success is determined based on the first time corresponding to the determination of the change in the one or more received electrical signals.

18 . The method of claim 16 , wherein the treatment success is further determined based on a spatial pattern of the change in the one or more received electrical signals.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 27, 2026
From: SCHULER, BRIAN T.; BERNSTEIN, DAVID T.; MATSUURA, DAVID G.; SIMPSON, PHILIP J.; EISENHARDT, PATRICIA E.; SCHULER SCIENTIFIC SOLUTIONS
To: BIOZONAL ID LLC
Reel/Frame 073927/0683 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 2, 2021
From: SCHULER, BRIAN; SIU, NELSON; SIMPSON, PHILIP J.; MATSUURA, DAVID G.
To: BIOZONAL ID, LLC
Reel/Frame 055807/0532 →
Continuity (4)
Continuation In Part 15396309 · Dec 30, 2016
Provisional Application 62947471 · Dec 12, 2019
Provisional Application 62273268 · Dec 30, 2015
Related Publication 20210177509A1 · Jun 17, 2021
References Cited (99)
US 3326207A · Egan · 1967 [cited by applicant]
US 3996938A · Clark · 1976 [cited by applicant]
US 4304239A · Perlin · 1981 [cited by applicant]
US 4519403A · Dickhudt · 1985 [cited by applicant]
US 4552127A · Schiff · 1985 [cited by applicant]
US 4649924A · Taccardi · 1987 [cited by applicant]
US 4660571A · Hess et al. · 1987 [cited by applicant]
US 4699147A · Chilson et al. · 1987 [cited by applicant]
US 4776349A · Nashef et al. · 1988 [cited by applicant]
US 4824435A · Giesy et al. · 1989 [cited by applicant]
US 4921484A · Hillstead · 1990 [cited by applicant]
US 4940064A · Desai · 1990 [cited by applicant]
US 5156151A · Imran · 1992 [cited by applicant]
US 5222501A · Ideker et al. · 1993 [cited by applicant]
US 5255678A · Deslauriers · 1993 [cited by applicant]
US 5263493A · Avitall · 1993 [cited by applicant]
US 5277207A · Stern et al. · 1994 [cited by applicant]
US 5311866A · Kagan et al. · 1994 [cited by applicant]
US 5313943A · Houser et al. · 1994 [cited by applicant]
US 5345936A · Pomeranz et al. · 1994 [cited by applicant]
US 5411025A · Webster, Jr. · 1995 [cited by applicant]
US 5690642A · Osborne et al. · 1997 [cited by applicant]
US 5860974A · Abele · 1999 [cited by applicant]
US 5891136A · McGee et al. · 1999 [cited by applicant]
US 5972026A · Laufer et al. · 1999 [cited by applicant]
US 6053913A · Tu et al. · 2000 [cited by applicant]
US 6142993A · Whayne et al. · 2000 [cited by applicant]
US 6240307B1 · Beatty et al. · 2001 [cited by applicant]
US 6475179B1 · Wang et al. · 2002 [cited by applicant]
US 6529756B1 · Phan et al. · 2003 [cited by applicant]
US 6748255B2 · Fuimaono et al. · 2004 [cited by applicant]
US 6899726B2 · Larnard et al. · 2005 [cited by applicant]
US 6970730B2 · Fuimaono et al. · 2005 [cited by applicant]
US 7070594B2 · Sherman · 2006 [cited by applicant]
US 7149563B2 · Fuimaono et al. · 2006 [cited by applicant]
US 7236821B2 · Cates et al. · 2007 [cited by applicant]
US 7371231B2 · Rioux et al. · 2008 [cited by applicant]
US 7567841B2 · Chan · 2009 [cited by applicant]
US 7569052B2 · Phan et al. · 2009 [cited by applicant]
US 7691119B2 · Farnan · 2010 [cited by applicant]
US 7722604B2 · Brown, III et al. · 2010 [cited by applicant]
US 7959627B2 · Utley et al. · 2011 [cited by applicant]
US 8187266B2 · Dickens et al. · 2012 [cited by applicant]
US 8398624B2 · Rioux et al. · 2013 [cited by applicant]
US 8702694B2 · Wallace et al. · 2014 [cited by applicant]
US 9060756B2 · Bencini et al. · 2015 [cited by applicant]
US 9179970B2 · Utley et al. · 2015 [cited by applicant]
US 9381361B2 · Giovangrandi et al. · 2016 [cited by applicant]
US 9855089B2 · Lalonde et al. · 2018 [cited by applicant]
US 10945780B2 · Lalonde · 2021 [cited by applicant]
US 20010029366A1 · Swanson et al. · 2001 [cited by applicant]
US 20020107511A1 · Collins et al. · 2002 [cited by applicant]
US 20030069606A1 · Girouard et al. · 2003 [cited by applicant]
US 20030135233A1 · Bates et al. · 2003 [cited by applicant]
US 20030236495A1 · Kennedy · 2003 [cited by applicant]
US 20040078036A1 · Keidar · 2004 [cited by applicant]
US 20040082947A1 · Oral et al. · 2004 [cited by applicant]
US 20040092787A1 · Hughett et al. · 2004 [cited by applicant]
US 20040106896A1 · Lee et al. · 2004 [cited by applicant]
US 20040143256A1 · Bednarek · 2004 [cited by applicant]
US 20040254621A1 · Jones et al. · 2004 [cited by applicant]
US 20050049585A1 · Fleischman et al. · 2005 [cited by applicant]
US 20050171525A1 · Rioux et al. · 2005 [cited by applicant]
US 20060235474A1 · Demarais · 2006 [cited by examiner]
US 20060258951A1 · Bleich · 2006 [cited by examiner]
US 20080281391A1 · Macadam et al. · 2008 [cited by applicant]
US 20090299355A1 · Bencini et al. · 2009 [cited by applicant]
US 20100160906A1 · Jarrard · 2010 [cited by applicant]
US 20110034912A1 · de Graff et al. · 2011 [cited by applicant]
US 20120101413A1 · Beetel et al. · 2012 [cited by applicant]
US 20130030425A1 · Stewart et al. · 2013 [cited by applicant]
US 20130035576A1 · O'Grady et al. · 2013 [cited by applicant]
US 20130184706A1 · Gelbart et al. · 2013 [cited by applicant]
US 20130261471A1 · Saha et al. · 2013 [cited by applicant]
US 20140046320A1 · Kappel et al. · 2014 [cited by applicant]
US 20140142570A1 · Bakczewitz et al. · 2014 [cited by applicant]
US 20140243809A1 · Gelfand · 2014 [cited by examiner]
US 20150005762A1 · Belk et al. · 2015 [cited by applicant]
US 20150057563A1 · Kowalski et al. · 2015 [cited by applicant]
US 20150105770A1 · Amit · 2015 [cited by applicant]
US 20150119868A1 · Lalonde et al. · 2015 [cited by applicant]
US 20150250399A1 · Laughner et al. · 2015 [cited by applicant]
US 20150359487A1 · Coulombe · 2015 [cited by applicant]
US 20160082179A1 · Toth · 2016 [cited by examiner]
US 20160287323A1 · Yagi et al. · 2016 [cited by applicant]
US 20170143415A1 · Laughner et al. · 2017 [cited by applicant]
US 20170189106A1 · Schuler et al. · 2017 [cited by applicant]
US 20210236816A1 · Waldstreicher et al. · 2021 [cited by applicant]
EP 0771547A2 · 1997 [cited by applicant]
EP 1946712A1 · 2008 [cited by applicant]
WO WO2000051683 · 2000 [cited by applicant]
WO WO2009129484 · 2009 [cited by applicant]
WO WO2017117582 · 2017 [cited by applicant]
WO WO2018212840 · 2018 [cited by applicant]
WO WO2021119479 · 2021 [cited by applicant]
WO WO2023114991 · 2023 [cited by applicant]
U.S. Appl. No. 15/396,309, filed Dec. 30, 2016, Tissue Mapping and Treatment. [cited by applicant]
Franceschi, Frederic; Dubuc, Marc; Guerra, Peter G.; Khairy, Paul: “Phrenic nerve monitoring with diaphragmatic electromyography during cryoballoon ablation for atrial fibrillation: Thefirst human application”, Heart Rh… [cited by applicant]
Okishige Kaoru et al: “Quick, safe, and effective maneuver to prevent phrenic nerve injury during cryoballoon ablation of atrial fibrillation”, Journal of Interventional Cardiac Electrophysiology, Springer New York LLC,… [cited by applicant]